MAUDE Adverse Event Report: SPINEOLOGY INC. ELITE; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	541-0014
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Missing Value Reason (3192)
Date of Event	10/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The implant was removed and replaced with another of the same design approximately 11 weeks post-op.Reportedly x-ray imaging indicated that the implant collapsed, and the bolt was broken.No information about the patient's condition is available.

• Brand Name: ELITE
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): SPINEOLOGY INC.; 7800 third street n.; suite 600; saint paul MN 55128 5455
• MDR Report Key: 8042082
• Report Number: 2135156-2018-00010
• Device Sequence Number: 19158209
• Product Code: MAX
• UDI-Device Identifier: M7405410014
• UDI-Public: M7405410014
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K162879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2022
• Device Catalogue Number: 541-0014
• Device Lot Number: S80440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR